qsymia and Weight-Loss

The treatment of obesity is often met with a myriad of challenges in the primary care setting. Nevertheless, a modest 5% weight loss is considered clinically significant and may be associated with health benefits. Phentermine/topiramate (Qsymia), available in the United States since September 2012, achieves clinically meaningful weight loss along with improvements in weight-related comorbidities. This combination drug therapy could be an additional tool for primary care providers in their quest for effective management of obesity. Special precautions and close monitoring are indicated when prescribing phentermine/topiramate for women of childbearing potential. Monitoring of heart rate and psychiatric and cognitive side effects is important.

Topics: Anti-Obesity Agents; Clinical Trials, Phase III as Topic; Drug Administration Schedule; Drug Combinations; Drug Monitoring; Fructose; Humans; Obesity; Phentermine; Primary Health Care; Topiramate; Treatment Outcome; United States; Weight Loss

Obesity is a major public health concern associated with increased morbidity and mortality. Its prevalence is rising worldwide mainly due to modern lifestyle habits. Several mechanisms like inflammation, endothelial dysfunction, increased sympathetic tone, high leptin and insulin concentrations as well as enhanced thrombogenesis are implicated to the emergence and progress of cardiovascular disease. Although, changes in the lifestyle remain the cornerstone of antiobesity treatment, alone do not always provide the desired weight loss. Often, the addition of pharmacotherapy or bariatric surgery is considered the treating option for patients meeting eligibility criteria. Although, bariatric surgery is limited to patients with a high body mass index due to the risks of the procedures, the effects of anti-obesity medication on cardiovascular outcome are still unclear. Several anti-obesity drugs have been abandoned because of serious adverse events. Qsymia is a combination of phentermine and topiramate used for obesity treatment. Administration of this drug reduces body weight and has favorable effects in various metabolic and anthropometric parameters. However, there are concerns regarding cardiovascular safety of this drug. In this review, we are going to present the history of current antiobesity medication focusing on the combination of phentermine and topiramate and recent patents.

Topics: Animals; Anti-Obesity Agents; Cardiovascular Diseases; Delayed-Action Preparations; Drug Combinations; Fructose; Humans; Obesity; Patents as Topic; Phentermine; Topiramate; Treatment Outcome; Weight Loss

Obesity is a chronic disease universally defined as an excess of adipose tissue resulting in body mass index (BMI) > 30.0 kg/m2. Over the past few years, the concept of prevention has gained increased awareness, thus leading to the development of additional pharmaceutical options for the treatment of obesity since 2012. Treating obesity revolves around an individualized, multi-disciplinary approach with additional focus on a healthy and supportive lifestyle to maintain the weight loss. [Full article available at http://rimed.org/rimedicaljournal-2017-03.asp].

Topics: Anti-Obesity Agents; Benzazepines; Body Mass Index; Bupropion; Drug Combinations; Fructose; Humans; Lactones; Liraglutide; Naltrexone; Obesity; Orlistat; Phentermine; Weight Loss

Phase 3 clinical trial results reveal that Qsymia is a clinically effective long-term treatment for obesity, but whether this treatment is cost-effective compared to a diet and lifestyle intervention has yet to be explored.. To quantify the incremental cost-effectiveness of Qsymia (phentermine and topiramate extended-release) for health-related quality of life improvements.. Estimates are based on cost and quality of life outcomes from a 56-week, multicenter, placebo-controlled, phase 3 clinical trial undertaken in 93 health centers in the US. Participants were overweight and obese adults (aged 18-70 years) with a body-mass index of 27-45 kg/m(2) and two or more comorbidities (hypertension, dyslipidemia, diabetes or pre-diabetes or abdominal obesity). The intervention was diet and lifestyle advice plus the recommended dose of Qsymia (phentermine 7.5 mg plus topiramate 46.0 mg) vs. control, which included diet and lifestyle advice plus placebo. The study was from the payer perspective. Costs included the prescription cost, medication cost offsets and physician appointment costs. Effectiveness was measured in terms of quality-adjusted life years gained (QALYs). The main outcome measure was incremental cost per QALY gained of the intervention relative to control.. Our base-case model, in which participants take Qsymia for 1 year with benefits linearly decaying over the subsequent 2 years, generates an incremental cost-effectiveness ratio (ICER) of $48,340 per QALY gained. Using the base-case assumptions, probabilistic sensitivity analyses reveal that the ICER is below $50,000 per QALY in 54 % of simulations. However, results are highly dependent on the extent to which benefits are maintained post medication cessation. If benefits persist for only 1 year post cessation, the ICER increases to $74,480.. Although base-case results suggest that Qsymia is cost-effective, this result hinges on the time on Qsymia and the extent to which benefits are maintained post medication cessation. This should be an area of future research.

Topics: Anti-Obesity Agents; Clinical Trials, Phase III as Topic; Cost-Benefit Analysis; Drug Combinations; Drug Costs; Fructose; Humans; Obesity; Phentermine; Quality-Adjusted Life Years; Randomized Controlled Trials as Topic; Weight Loss

Topics: Appetite Depressants; Benzazepines; Drug Combinations; Fructose; Humans; Obesity; Overweight; Phentermine; Weight Loss

Topics: Adult; Anti-Obesity Agents; Benzazepines; Dose-Response Relationship, Drug; Drug Combinations; Drugs, Investigational; Female; Fructose; Heart Valve Diseases; Humans; Male; Obesity; Phentermine; Pregnancy; Tachycardia; Teratogens; Topiramate; Weight Loss

Prescribing medications for off-label uses is not illegal. Off-label prescribing includes using medications for unapproved indications; using a drug outside of the recommended dosage range or duration of use; using a drug in certain unapproved patient populations, such as those defined by age, sex, or particular clinical parameters; or intentionally using a medication in a patient who has a known contraindication. Medications would be considered appropriate for off-label use based on their known clinical pharmacology, evidence from clinical studies, and sometimes from the personal experience of the prescriber. The decision to use a drug off label should be based on a careful assessment of the patient's treatment history and the drug's potential risks and benefits. Patients should be given adequate informed consent about how the drug is being used off label and why, along with appropriate information about known risks and side effects.

Topics: Anti-Obesity Agents; Anticonvulsants; Bipolar Disorder; Child; Delayed-Action Preparations; Drug Approval; Drug Combinations; Evidence-Based Medicine; Fructose; Humans; Informed Consent; Off-Label Use; Parental Consent; Phentermine; Practice Patterns, Physicians'; Randomized Controlled Trials as Topic; Treatment Outcome; Weight Loss

Topics: Anti-Obesity Agents; Benzazepines; Drug Combinations; Drug Interactions; Fructose; Humans; Obesity; Overweight; Phentermine; Receptor, Serotonin, 5-HT2C; Serotonin 5-HT2 Receptor Agonists; Treatment Outcome; Weight Loss

Qnexa (VI-0521) is an investigational fixed-dose combination drug of phentermine and topiramate currently in Phase III clinical trials for the treatment of obesity. Vivus, Inc. has demonstrated efficacy of their product and are currently addressing FDA safety concerns with the possibility of a New Drug Application (NDA) resubmission.

Topics: Anti-Obesity Agents; Appetite Depressants; Clinical Trials, Phase III as Topic; Comorbidity; Double-Blind Method; Drug Approval; Drug Combinations; Fructose; Humans; Obesity; Overweight; Phentermine; Randomized Controlled Trials as Topic; Topiramate; Treatment Outcome; United States; United States Food and Drug Administration; Weight Loss